FDA Grants Gilteritinib Fast Track Designation for AML

October 11, 2017 – The FDA has granted Fast Track designation to gilteritinib for adult patients with FLT3 mutation-positive relapsed/refractory acute myeloid leukemia (AML), according to Tokyo-based Astellas Pharma. Gilteritinib is an investigational compound that has demonstrated inhibitory activity against FLT3 internal tandem duplication as well as FLT3 tyrosine kinase domain, two common types of FLT3 mutations present in approximately 1/3 of patients with AML. The drug … (leggi tutto)